Pharmacovigilance systems and methods

Abstract

A system for monitoring people's activity and/or health while at the same time preserving their privacy. Monitoring is accomplished by detecting state of people's electronic devices, e.g., a smart phone. When use of the monitored device deviates from an expected use an alert is automatically sent to a monitoring device. The relationships between users are optionally maintained in a social network. Privacy is strictly protected by reporting only deviations from use according to rules set by the person being monitored. Optionally an activity monitoring system receives data from multiple sources such as a home security system, IoT devices and a smartphone. The use of multiple data sources provides an improved activity monitoring system capable of distinguishing normal activity from abnormal activity that may be indicative of a physical or mental health condition. Variations in the monitored activity are used to identify potential health issues for the user. If a health issue is identified, an alert may be sent to a remote third party. A human augmented positive feedback loop is used to generate data for training of machine learning systems.

What is claimed is: 
     
         1 . A pharmacovigilance system comprising:
 A) a sensor configured to detect movement or location of a patient;   B) activity logic configured to determine an activity level of the patient based on the detected movement or location of the patient;   C) threshold logic configured to set one or more criteria for generating an alert, based on an identity of a pharmaceutical prescribed to the patient;   D) alert logic configured to generate an alert when the determined activity level of the patient based on the detected movement or location of the patient satisfies the one or more criteria for generating the alert;   E) notice logic configured to send the alert based on (i) an identity of a pharmaceutical prescribed to the patient and/or (ii) when the determined activity level of the patient based on the detected movement or location of the patient to a caregiver of the patient; and   D) a microprocessor configured to execute at least the threshold logic.   
     
     
         2 . The pharmacovigilance system of  claim 1 , wherein the sensor is disposed on a smartphone. 
     
     
         3 . The pharmacovigilance system of  claim 1 , wherein the sensor is one of a plurality of sensors configured to detect the movement or location, the plurality of sensors being disposed in different devices. 
     
     
         4 . The pharmacovigilance system of  claim 1 , wherein the activity logic is distributed among several devices. 
     
     
         5 . The pharmacovigilance system of  claim 1 , wherein the activity logic is configured to be executed on a mobile device. 
     
     
         6 . The pharmacovigilance system of  claim 1 , wherein the activity logic is further configured to filter location data of the patient. 
     
     
         7 . The pharmacovigilance system of  claim 1 , wherein the activity logic is configured to calculate a statistical function of the movement. 
     
     
         8 . The pharmacovigilance system of  claim 1 , wherein the threshold logic is configured to set a threshold representing a boundary between expected and unexpected levels of activity of the patient based on the detected movement or location of the patient. 
     
     
         9 . The pharmacovigilance system of  claim 8 , wherein the threshold logic is configured to set a threshold above or below which the activity level of the patient based on the detected movement or location of the patient is unexpected, in response to the patient receiving a pharmaceutical selected from a group consisting of an anti-depressant, an anti-psychotic, levodopa, Interferon-alpha, corticosteroids and anabolic-androgenic steroids, dopaminergic anti-Parkinsonian drugs, thyroxine, Digitalis/digoxin, Antiepileptic drugs, iproniazid, isoniazid, sympathomimetic drugs, chloroquine, baclofen, alprazolam, captopril, amphetamine and phencyclidine. 
     
     
         10 . The pharmacovigilance system of  claim 9 , wherein the criteria set by the threshold logic comprises criteria for several different measures of patient activity. 
     
     
         11 . The pharmacovigilance system of  claim 9 , wherein the criteria set by the threshold logic comprises criteria based on an activity history for the patient. 
     
     
         12 . The pharmacovigilance system of  claim 1 , wherein the alert comprises a visual representation of the activity of the patient. 
     
     
         13 . The pharmacovigilance system of  claim 1 , wherein the notice logic is configured to send the alert in an e-mail or a medical service portal. 
     
     
         14 . The pharmacovigilance system of  claim 1 , wherein the threshold logic is configured to receive approval of the criteria from a medical caregiver. 
     
     
         15 . The pharmacovigilance system of  claim 1 , wherein the threshold logic is configured to set the criteria using a machine learning system. 
     
     
         16 . The pharmacovigilance system of  claim 1 , wherein the alert logic is configured to use a machine learning system to determine when the determined activity level satisfies the criteria. 
     
     
         17 . The pharmacovigilance system of  claim 1 , wherein the activity logic is configured to store the activity level in an electronic medical record. 
     
     
         18 . A method of providing pharmacovigilance, the method comprising:
 A) obtaining a background activity level for a patient;   B) determining one or more criteria for generating an alert, the one or more criteria comprising at least one of a patient identity or dosage of a pharmaceutical provided to the patient;   C) receiving sensor data representative of movement of the patient;   D) determining an activity level for the patient based on the sensor data;   E) generating an alert responsive to the activity level meeting the criteria for generating an alert; and   F) sending the alert to a medical provider of the patient.   
     
     
         19 . The method of providing pharmacovigilance of  claim 18 , further providing a smartphone as part of obtaining the background activity level for the patient. 
     
     
         20 . The method of providing pharmacovigilance of  claim 18 , further providing a plurality of sensors configured to detect the movement or location, the plurality of sensors being disposed in different devices as part of obtaining the background activity level for the patient. 
     
     
         21 . The method of providing pharmacovigilance of  claim 18 , further providing activity logic distributed among several devices as part of obtaining the background activity level for the patient. 
     
     
         22 . The method of providing pharmacovigilance of  claim 21 , further providing activity logic configured to be executed on a mobile device. 
     
     
         23 . The method of providing pharmacovigilance of  claim 21 , further providing activity logic configured to filter location data of the patient. 
     
     
         24 . The method of providing pharmacovigilance of  claim 21 , further providing activity logic configured to calculate a statistical function of the patient's movement. 
     
     
         25 . The method of providing pharmacovigilance of  claim 18 , further providing threshold logic configured to set a threshold representing a boundary between expected and unexpected levels of patient activity. 
     
     
         26 . The method of providing pharmacovigilance of  claim 25 , further providing threshold logic configured to set a threshold above or below which an activity level is unexpected, in response to the patient receiving a pharmaceutical selected from a group consisting of an anti-depressant, an anti-psychotic, levodopa, Interferon-alpha, corticosteroids and anabolic-androgenic steroids, dopaminergic anti-Parkinsonian drugs, thyroxine, Digitalis/digoxin, Antiepileptic drugs, iproniazid, isoniazid, sympathomimetic drugs, chloroquine, baclofen, alprazolam, captopril, amphetamine and phencyclidine. 
     
     
         27 . The method of providing pharmacovigilance of  claim 25 , further providing threshold logic comprising criteria for several different measures of patient activity. 
     
     
         28 . The method of providing pharmacovigilance of  claim 25 , further providing threshold logic comprising criteria based on an activity history for the patient. 
     
     
         29 . The method of providing pharmacovigilance of  claim 18 , further generating an alert comprising a visual representation of the activity of the patient. 
     
     
         30 . The method of providing pharmacovigilance of  claim 18 , further generating an alert comprising communication by an e-mail or a medical service portal. 
     
     
         31 . The method of providing pharmacovigilance of  claim 18 , further providing approval of the criteria from a medical caregiver. 
     
     
         32 . The method of providing pharmacovigilance of  claim 18 , further providing threshold logic configured to set the criteria using a machine learning system. 
     
     
         33 . The method of providing pharmacovigilance of  claim 18 , further providing alert logic configured by a machine learning system to determine when the patient's determined activity level satisfies the patient's criteria. 
     
     
         34 . The method of providing pharmacovigilance of  claim 18 , further storing the patient's activity level in an electronic medical record.